NEAL R. GROSS - USDA-APHIS · In addition to tonight's webinar two . 21. more have been scheduled for May 12th and May 20th. NEAL R. GROSS. COURT REPORTERS AND TRANSCRIBERS 1323 RHODE

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UNITED STATES DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE + + + + + PUBLIC ENGAGEMENT WEBINAR ON THE REGULATION OF BIOTECHNOLOGY + + + + + WEDNESDAY MAY 6, 2015 + + + + +

The Webinar convened in the Oklahoma City Memorial Conference Center, 4700 River Road, Riverdale, Maryland, at 6:00 p.m., Dick George, BRS Communications Branch Chief, presiding. USDA STAFF PRESENT: DICK GEORGE, BRS Communications Branch Chief NEIL HOFFMAN, Science Advisor for the Office of

the Deputy Administrator, BRS COMMENTERS: ADAM COSTANZA KRISTINA HUBBARD BRIAN LEHMANN AMALIE LIPSTREU CLINT NESBITT GENNA REED

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com

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T-A-B-L-E O-F C-O-N-T-E-N-T-S Opening remarks Dick George .................................. 3 Neil Hoffman ................................. 3 Public Comment Genna Reed .................................. 13 Kristina Hubbard ............................ 21 Clint Nesbitt ............................... 29 Adam Costanza ............................... 37 Amalie Lipstreu ............................. 43 Brian Lehmann ............................... 53


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P-R-O-C-E-E-D-I-N-G-S 1

6:00 p.m. 2

MR. GEORGE: Good evening and welcome 3

to our public engagement webinar on APHIS 4

Biotechnology Regulations. My name is Dick George 5

and I'm the Communications Branch Tech Chief at 6

Biotechnology Regulatory Services, or BRS. We're 7

part of APHIS, the Animal and Plant Health 8

Inspection Service, and agency of the U.S. 9

Department of Agriculture. 10

Joining me is Dr. Neil Hoffman, Science 11

Advisor in BRS' Office of the Deputy Administrator. 12

DR. HOFFMAN: Our purpose today is to 13

receive your comments on several subject areas 14

regarding the regulation of biotechnology by 15

APHIS. We value your input and are pleased that 16

you joined us today either to make a public comment 17

or to listen to the comments of others. 18

Background information is available at 19

our Web site at 20

www.aphis.usda.gov/APHISVirtualMeetings/. 21


4

In addition to tonight's webinar, two 1

more have been scheduled for May 12th and May 20th. 2

PARTICIPANT: They can't hear. 3

MR. GEORGE: Okay. Well, we're going 4

to wait until everybody can hear. And we may start 5

again. So if you can hear us, we're understanding 6

that some folks are unable to hear us, so we're 7

going to get that straightened out before we 8

continue. 9

AUTOMATED PHONE OPERATOR: All 10

participants are now in interactive talk mode. 11

PARTICIPANT: Can you speak so they 12

can -- 13

MR. GEORGE: Sure. Sure. 14

PARTICIPANT: -- so they can hear -- 15

(Simultaneous speaking) 16

MR. GEORGE: So, okay. I'm providing 17

a little bit of sound so that we can test whether 18

or not the sound is reaching those of you that are 19

on the call. We apologize for any inconvenience, 20

but we want to get this right before we start so 21


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that everyone can hear, not only us, but hear each 1

other as well. So I'm going to keep talking just 2

so that the sound can be tested and we can make sure 3

that it's getting through to those of you that are 4

on the call. 5

I'll take this opportunity to let you 6

know that in addition to tonight's webinar, there 7

will be another webinar next week on Tuesday the 8

12th, and then another one on the 20th, which is 9

a Wednesday. 10

Okay. Can people hear me now? I'll 11

raise my voice. Is that better? I'm looking for 12

some -- 13

PARTICIPANT: Move the microphone 14

closer. 15

MR. GEORGE: Okay. We'll get the 16

microphone closer. 17

Okay. Is that better? I'm hearing 18

some sound. 19

PARTICIPANT: No, they're not hearing 20

you. 21


6

MR. GEORGE: Okay. I will thank all of 1

those who are on the phone for their patience as 2

we try to get this worked out. 3

PARTICIPANT: Keep talking so they can 4

test. 5

MR. GEORGE: Okay. And I've been 6

asked to keep talking, so I will. I want to thank 7

everybody for joining us on this first of three 8

webinars that are planned for the month of May. We 9

welcome your comments. In a few minutes once we 10

know that this is working, I'll give the 11

instructions for exactly how we're going to 12

proceed. 13

Some of you have registered for the 14

meeting and those of you who have registered to 15

comment will be the first speak, and we will give 16

you that opportunity -- 17

AUTOMATED PHONE OPERATOR: All 18

participants are now in listen-only mode. 19

MR. GEORGE: -- we'll give you that 20

opportunity in the same order in which you 21


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registered. 1

In the meantime, our apologies for the 2

delay and thank you for your patience. 3

This meeting is scheduled to until 9:00 4

p.m. Eastern Time tonight, and we welcome comments 5

of all who care to comment on biotechnology 6

regulations. 7

And I'm looking around now to see if 8

we've licked this. We think perhaps we have, but 9

we'll give it another minute or two. 10

PARTICIPANT: Now they can hear you. 11

MR. GEORGE: People can how hear me. 12

I'm understanding that I can be heard. Is that 13

correct? 14

PARTICIPANT: Yes. Yes, yes, yes. 15

Excellent. 16

MR. GEORGE: Okay. Everybody is 17

reporting to me that we can now be heard, and so 18

we will now -- we'll start again since we were so 19

close to the beginning and because apparently many 20

of you could not hear our introduction. So we 21


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shall start from the top. 1

Good evening and welcome to our public 2

engagement webinar on APHIS Biotechnology 3

Regulations. My name is Dick George. I'm the 4

Communications Branch Chief at Biotechnology 5

Regulatory Services, or BRS. We're part of APHIS, 6

the Animal and Plant Health Inspection Service, an 7

agency of the U.S. Department of Agriculture. 8

Joining me is Dr. Neil Hoffman, Science 9

Advisor in BRS' Office of the Deputy Administrator. 10

DR. HOFFMAN: Our purpose today is to 11

receive your comments on several subject areas 12

regarding the regulation of biotechnology by 13

APHIS. We value your input are pleased that you 14

joined us today either to make a public comment or 15

to listen to the comments of others. 16

Background information is available at 17

our Web site at 18

www.aphis.usda.gov/APHISVirtualMeetings/. 19

In addition to tonight's webinar two 20

more have been scheduled for May 12th and May 20th. 21


9

If you prefer to make a written comment 1

instead of a spoken one, you can do so by going to 2

www.regulations.gov through June 22nd. Enter 3

APHIS-2015-0036 in the search box and this will 4

take you to the pages where you can make your 5

comment. You can go to regulations.gov any time 6

up until June 22nd to leave a written public 7

comment, or you can make a spoken comment here at 8

our meeting, which will go until 9:00 a.m. Eastern 9

Daylight Time. 10

Whether spoken or written, your comment 11

will become part of the public record. A 12

transcript of your spoken comments will be posted 13

to the website in the next three weeks. 14

Today we're here to listen and to 15

receive your input only, not to answer questions 16

about biotechnology regulations. 17

MR. GEORGE: APHIS is considering 18

amending its current regulations and seeks your 19

input on the following questions: The first 20

question: Should APHIS regulate based on the 21


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characteristics of biotechnology products and the 1

potential risks they may pose or by the process by 2

which they were created? In either case, what 3

criteria should be used to determine what APHIS 4

regulates? Are thereir products and processes 5

APHIS should not regulate? 6

Two: The Plant Protection Act gives 7

APHIS the authority to protect plant health through 8

regulatory programs. APHIS has implemented the 9

Plant Pest Authority as part of their biotechnology 10

regulations. Should APHIS add noxious weed 11

provisions to their biotechnology regulations? 12

And if so, how? What protection goals should APHIS 13

consider? 14

DR. HOFFMAN: Three: Are there legal 15

authorities given to USDA outside the Plant 16

Protection Act that APHIS should examine to 17

regulate or oversee the products of biotechnology? 18

What are they and how would they be used? 19

Four: What non-regulatory solutions 20

or policy alternatives could or should be 21


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considered to complement APHIS' regulatory 1

program? 2

MR. GEORGE: We have asked commenters 3

to pre-register to comment. We will ask those 4

commenters to go first. Each commenter will have 5

up to seven minutes to speak with a prompt at five 6

minutes that there are two minutes remaining. 7

After all that have signed up to speak have done 8

so, we will ask others on the call if they would 9

care to comment and give you the same opportunity. 10

If we reach a point where all who choose to comment 11

have commented and there is still time, we will 12

invite those who have already commented to come 13

back to make additional comments, if they care to. 14

With that, we will begin to take your 15

comments. We ask that you please say your name, 16

spell your name, and if you represent an 17

organization, please let us know that so that our 18

court reporter can capture this information 19

correctly. 20

Now, let me take a look here. Our first 21


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registered commenter is Alejandra BedollaDiaz. 1

Please forgive me if I have butchered your name. 2

And if you are on the line, we would invite you to 3

be the first to make a comment, and you would do 4

that by pressing one, then zero on your telephone 5

keypad to let us know that you're there. 6

AUTOMATED PHONE OPERATOR: Your 7

conference is now in question and answer mode. To 8

summon each question, press one, then zero. 9

MR. GEORGE: Do we have Alejandra? 10

(No audible response) 11

MR. GEORGE: No? Okay. Having not 12

heard from Alejandra, we'll go to the second person 13

who has pre-registered to comment, and that's Randy 14

Gordon. 15

Randy, if you're there, would you 16

please one, then zero on your telephone keypad? 17


MR. GEORGE: Randy Gordon is the second 19

person who has pre-registered to comment. 20

Randy, if you're there would you please 21


13

press one, then zero on your telephone keypad? 1


MR. GEORGE: So we're not hearing also 3

from Randy. So we shall go to our third person 4

who's pre-registered. That's Genna Reed. 5

PARTICIPANT: Yes, she is. 6

MR. GEORGE: Genna, if you're there, 7

please press one, then zero on your keypad and go 8

ahead with your comment. 9

AUTOMATED PHONE OPERATOR: You have 10

one question remaining. 11

MS. REED: Hi, this Genna. 12

MR. GEORGE: Hi, Genna. Thanks. 13

MS. REED: Okay. Good afternoon. My 14

name is Genna Reed and I am here representing Food 15

and Water Watch, a non-profit consumer advocacy 16

group that supports safe, accessible and 17

affordable food for consumers and fair access to 18

markets for farmers. 19

We are glad to see that the USDA has 20

decided to forego the finalization of its 2008 rule 21


14

for the regulation of genetically engineered 1

plants. We hope that the USDA takes this 2

opportunity to strengthen its regulations under 3

the authority of the Plant Protection Act to 4

protect farmers and consumers. 5

The USDA's current regulatory system 6

for genetically engineered plants is broken. 7

Since the introduction of GMO crops a lack of 8

oversight has led to the stray presence of 9

unapproved GMO crops, contamination of organic and 10

non-GMO crops with GMO content and the decision to 11

allow certain GMO crops to be sold and planted with 12

zero regulatory scrutiny. 13

Food and Water Watch would like to see 14

the USDA improve its monitoring and inspections of 15

experimental field trials to avoid contamination 16

that exists that are continuing to occur due to a 17

lack of oversight. This new regulatory exemption 18

includes contamination prevention measures in 19

addition to compensation of parties harmed by 20

contamination events. This burden should not be 21


15

borne by the farmers who are contaminated by GMO 1

presence through no fault of their own. Instead, 2

the USDA should work with patent-holding companies 3

to create a fund that will compensate economically 4

harmed farmers. 5

Additionally, the deregulation process 6

should be altered so that there is 7

co-commercialization monitoring to avoid 8

incidents such as stray GMO wheat found in Oregon 9

and GMO alfalfa found in Washington, and the 10

protections emerged from accidental exposure to 11

risky experimental crops like those producing 12

pharmaceuticals. Finally, no GMO products should 13

be permitted to be commercialized without full 14

review of its unique risks to agriculture and the 15

environment. 16

And now I'll focus my attention on the 17

second question that the USDA posed to the public 18

regarding the noxious weed provision. First, Food 19

and Water Watch supports adding noxious weed 20

provisions to their regulation and to use them to 21


16

account for many of the scientific concerns that 1

have been raised about GMO crops, especially those 2

agricultural and environmental risks inherent in 3

many herbicide-tolerant crops. These risks 4

include the enhanced maintenance of existing 5

crops, the creation of new weeds through the flow 6

of genes to wild relatives and potential adverse 7

impacts on biodiversity and beneficial insects. 8

It is imperative that the USDA uses its authority 9

to more broadly interpret the noxious weed 10

provision, especially to include 11

herbicide-tolerant crops. 12

These crops, which make up the vast 13

majority of de-regulated genetically engineered 14

plants, have a range of adverse impacts on the 15

environment and public health. 16

Herbicide-tolerant crops have led to the 17

widespread occurrence of herbicide-resistant 18

weeds which have taken their toll on farmers 19

directly through additional farming and weeding 20

costs and have indirectly led to increased 21


17

herbicide use which can impact health risks on 1

residue. 2

The USDA has an increased 3

responsibility to protect the public since it has 4

approved the next generation of herbicide-tolerant 5

crops which can withstand applications of 2-4D and 6

Dicamba. This chemical process cannot be 7

continued indefinitely. Weed resistance to these 8

chemicals will continue to proliferate and 9

application of more noxious herbicides will 10

increase exponentially. The more herbicide we 11

apply to aggressive weeds like waterhemp, Palmer 12

amaranth, horseweed and kochia, the more likely it 13

is for biotech resistance to multiple herbicides 14

will spread in the United States. This likely 15

scenario will make farming more difficult and more 16

expensive for farmers. 17

Increased use of drift-prone 18

herbicides like 2,4-D and Dicamba to combat 19

resistant weeds will also impact organic and 20

non-GMO farmers. Dicamba and 2,4-D are known for 21


18

their negative impacts on target and non-target 1

plant development and cause abnormal growth and 2

death. Since Dicamba and 2,4-D are especially 3

prone to drift, any specialty crops like tomatoes, 4

grapes, potatoes that are grown near fields sprayed 5

with these herbicides could be damaged causing near 6

losses. 7

Not only will herbicide-tolerant crops 8

and weeds cause drift-associated farm-level 9

losses, but herbicide exposure will lead to health 10

issues. There are documented negative health 11

impacts associated with 2,4-D exposure. APHIS 12

must closely examine how these impacts would be 13

amplified with the more frequent use of 2,4-D on 14

2,4-D-tolerant corn and soybeans. Studies have 15

found that men who apply 2,4-D have lower sperm 16

counts and more sperm abnormalities than those 17

unexposed to the herbicide. And a study on 18

California farm workers concluded that working on 19

a farm that sprayed 2,4-D raises the risk of 20

Non-Hodgkin's lymphoma. 21


19

APHIS has the opportunity to stop this 1

scenario before it unfolds in U.S. agriculture by 2

exercising its Noxious Weed Authority to assess and 3

regulate herbicide-tolerant crop systems. In its 4

regulation of noxious weeds APHIS should include 5

protections against the following: enhanced 6

weediness of existing GMO crops, increased 7

herbicide and pesticide use and associated 8

impacts, like weed and pest resistance, gene flow 9

and other routes of seed and crop contamination, 10

animal and human health impact to the whole crop 11

system, damage to biodiversity, impact to 12

beneficial non-target organisms, and the ability 13

to disrupt markets, both domestic and export 14

markets. 15

Food and Water Watch urges the USDA to 16

thoroughly consider our recommendations for 17

approving regulatory oversight over genetically 18

engineered plants. Without a substantial overall 19

overhaul of the current system, the USDA would be 20

negotiating -- I'm finishing up. This is my last 21


20

sentence. 1

MR. GEORGE: Oh, perfect. 2

MS. REED: Without substantial overall 3

of the current system, the USDA would be neglecting 4

its responsibility to protect and preserve U.S. 5

agriculture for generations to come. Thank you 6

for your consideration of these comments. 7

MR. GEORGE: Thank you, Genna. 8

So I think at this time we shall ask 9

whether Alejandra BedollaDiaz has come onto to the 10

line. Do we have names, Robin? 11


MR. GEORGE: Okay. Or -- 13

PARTICIPANT: I mean, we have names, 14

but she's not in here. 15

MR. GEORGE: Randy Gordon? Has he 16

joined us? Randy Gordon, G-O-R-D-O-N. 17


MR. GEORGE: No? 19

PARTICIPANT: Not under that name. 20

MR. GEORGE: Okay. In that case we 21


21

shall go to our next registered commenter, who is 1

Kristina Hubbard. 2

PARTICIPANT: Yes. 3

MR. GEORGE: Can we open Kristina's 4

mic, please? 5

Kristina, you need to press one, then 6

zero, please. Press one, then zero. 7



MS. HUBBARD: Hi there. This is 10

Kristina Hubbard. Can you hear me? 11

MR. GEORGE: We sure can. 12

MS. HUBBARD: Hi there. The spelling 13

for my name is Kristina, K-R-I-S-T-I-N-A, Hubbard, 14

H-U-B-B-A-R-D. 15

MR. GEORGE: Thank you. 16

MS. HUBBARD: I'm the Efficacy 17

Director for Organic Seed Alliance, and we are a 18

national non-profit research, education advocacy 19

organization. And for more than a decade now we 20

have worked to promote policies that support the 21


22

success and integrity of organic feed systems 1

across the U.S. 2

And I want to begin by saying that we're 3

really grateful to the USDA for hosting these 4

webinars and initiating discussions on updating 5

regulations under the Plant Protection Act. We 6

plan to provide longer and more detailed written 7

comments later on in this process, but today I just 8

want to answer a couple of the question posed by 9

the Department for these webinars. 10

First of all, the Department has said 11

that it wants to explore policy alternatives and 12

has also asked of webinar participants whether 13

non-regulatory solutions exist. And I want to say 14

that while there may be other authorities worth 15

exploring in the context of improving oversight of 16

the products of biotechnology, additional existing 17

authorities that may exist shouldn't take the place 18

of developing new and stronger regulations under 19

the Plant Protection Act that better reflect the 20

Department's broad authority to address the full 21


23

range of direct and indirect impacts of 1

biotechnology products. 2

We're very supportive of the 3

Department's decisions to withdraw its 2008 4

proposal that would have updated these regulations 5

and we encourage the rapid development of new and 6

stronger regulations that we need to protect the 7

environment, human health and farmers and their 8

markets from impacts resulting from genetically 9

engineered crops, especially genetically 10

engineered crops that end up where they're not 11

wanted. 12

Furthermore, non-regulatory solutions 13

and other non-binding activities on their own have 14

not been effective to date in avoiding the problem 15

of contamination events in the feed and food supply 16

including at the experimental field trial stage as 17

we've heard have been the case over the last few 18

years, incidences involving alfalfa, wheat, corn. 19

Next, I want to respond to the first 20

question posed for this webinar, the question about 21


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whether APHIS should regulate based on the 1

characteristics of biotechnology products and the 2

potential risks they may pose, or by the process 3

by which they were created. Organic Seed Alliance 4

believes that APHIS should establish regulations 5

that not only capture all process of genetically 6

engineering. That could be the trigger. 7

Process-based regulations are the only practical 8

way to oversee these new technologies, and it 9

developed an approach, I want to add, that was 10

recommended in 2002 by the National Academy of 11

Sciences, again that the process should serve as 12

a trigger for regulation. 13

We're concerned that product-based 14

criteria would be almost impossible to establish 15

and predict before regulatory review and we're also 16

concerned that this approach would leave it up to 17

industry to determine which products should be 18

regulated. Among concerns for this approach would 19

include engendering trust among our trade 20

partners. 21


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We also believe there are no categories 1

of genetically engineered products that could go 2

completely unregulated. We believe that stronger 3

regulations are long overdue to protect the 4

environment, health and other sectors of 5

agriculture and trade. And it's important to 6

remember how much we've learned about the impact 7

of biotechnology since APHIS first developed 8

regulations in the 1980s. And again, in our 9

written comments we will go into more detail about 10

the criteria we think APHIS should use to determine 11

products for regulation and the protection goals 12

that should be included when analyzing new products 13

of biotechnology, especially under the 14

Department's Noxious Weed Authority. 15

But I'd want to end my comments here on 16

this call by summarizing the goal for stronger 17

regulation that we believe can and should be 18

implemented under the USDA's current authority as 19

provided by the Plant Protection Act. We feel that 20

APHIS can fill existing regulatory holes by 21


26

implementing its active authority, conducting 1

independent analyses of socioeconomic and 2

environmental impacts mandating correction 3

practices, especially on the part of owners and 4

users of genetically engineered crops. 5

Currently the entire burden of 6

protecting the organic and non-GMO sectors from the 7

unwanted presence of genetically engineered 8

crops -- that burden currently falls squarely on 9

the shoulders of those who not only choose to avoid 10

the technologies, but have to avoid the 11

technologies in order to meet the expectations of 12

their customers and the markets they serve. And 13

we also believe that there's a need to create a fair 14

compensation mechanism for when contamination 15

prevention fails so that those harmed by the 16

unwanted presence of genetically engineered crops 17

can recoup some of those losses. 18

We believe that we need strong 19

monitoring and oversight of experimental field 20

trials and there's a need to establish a monitoring 21


27

of products of biotechnology including after their 1

commercialization. 2

So with that I want to thank the 3

Department very much for withdrawing its 2008 4

proposal, for initiating this conversation and 5

taking very seriously the need to develop new 6

regulations under their authority of the Plant 7

Protection Act. Thank you again for the 8

opportunity to give comments. 9

MR. GEORGE: Thank you, Kristina. 10

Okay. So I will ask again whether 11

Alejandra has joined us or Randy Gordon? 12

PARTICIPANT: Randy Gordon is on the 13

webinar now. 14

MR. GEORGE: Okay. Randy, if you 15

would please press one, then zero on your telephone 16

keypad, we will be happy to receive your comments. 17


MR. GEORGE: Randy Gordon, if you're 19

hearing me, please press one, then zero on your 20

telephone keypad. We'll be happy to receive your 21


28

comments. 1


PARTICIPANT: I think he typed in 3

messages, too. 4

MR. GEORGE: Okay. He may have 5

stepped away, so we shall go ahead to our next 6

pre-registered commenter, who is Brian Lehmann. 7

Brian? 8

PARTICIPANT: He's here. 9

MR. GEORGE: Would you please press 10

one, then zero on your telephone keypad? 11


MR. GEORGE: Brian Lehmann, if you're 13

on the call and still wish to make a comment, please 14

press one, then zero on your telephone keypad and 15

let us know. 16

PARTICIPANT: I typed him a note, too. 17

MR. GEORGE: Nope? Okay. 18

PARTICIPANT: He's logged in. 19

MR. GEORGE: He's logged in, but he's 20

not there. So we shall move ahead to our next 21


29

pre-registered commenter, who is Clint Nesbitt. 1

PARTICIPANT: He's logged in. 2

MR. GEORGE: Clint, if you would press 3

one, then zero, please? 4


MR. GEORGE: I'm beginning to wonder if 6

we're having some kind of -- 7

PARTICIPANT: Clint's typing a 8

message. 9

MR. GEORGE: Okay. 10

PARTICIPANT: He says he's here. 11

MR. GEORGE: Okay. 12



MR. GEORGE: Here we go. 15

MR. NESBITT: Hello, this is Clint 16

Nesbitt. Can you hear me? 17

MR. GEORGE: We sure can, Clint. 18

MR. NESBITT: Very good. Thank you. 19

So this is Clint Nesbitt. I am the Food and 20

Agriculture Director of Regulatory Affairs at the 21


30

Biotechnology Industry Organization. BIO 1

represents nearly 1,000 companies, academic 2

institutions, statewide technology centers and 3

related organizations around the world. Thank you 4

for the opportunity to provide input as APHIS 5

considers possible revisions to its ag biotech 6

regulations. 7

APHIS plays and important role in 8

protecting U.S. agriculture by preventing the 9

introduction and dissemination of plant pests and 10

noxious weeds into the U.S. Since the early '90s 11

APHIS has used its Plant Pest Authority to oversee 12

the products of ag biotech on the basis that the 13

agency has reason to believe that some GE organisms 14

can plant pests. This has system has provided the 15

regulated community with the ability to conduct 16

research and development of beneficial new 17

products while assuring consumers and markets that 18

the products have undergone regulatory review and 19

have been appropriately evaluated before being 20

introduced into commerce. 21


31

But this regulatory system as it 1

currently operates has subjected developers to 2

increasingly overt compliance costs, unclear and 3

inconsistent requirements and uncertainty and 4

variability in the process driving up product 5

development costs and delaying their availability 6

to growers and consumers. APHIS has overseen tens 7

of thousands of field trials, hundreds of thousands 8

of genetic constructs and completed in-depth risk 9

assessments, and more than 100 deregulated 10

products and has never identified a single GE 11

organism to be a plant pest. This has resulted in 12

regulatory oversight that has grown to be vastly 13

disproportionate to the punitive risks that APHIS 14

uses to justify oversight at a high cost to 15

developers, growers, consumers and taxpayers. 16

APHIS should use this opportunity to 17

reflect on its nearly 30 years of experience 18

regulating ag biotech and to ensure that the level 19

oversight takes into account APHIS' familiarity 20

with the technology, the breadth of current 21


32

scientific knowledge and the long history of 1

safety. 2

Regarding APHIS' question No. 1, APHIS 3

should continue to impose regulations based upon 4

the plant pest risk posed to the product and not 5

the technology used to produce it. Furthermore, 6

the kind of risk overseen by APHIS should be 7

consistent with its authority under the Plant 8

Protection Act, or PPA. The PPA grants APHIS the 9

authority to prevent the introduction and 10

establishment of plant pests, and the existing 11

regulations implement that authority. Therefore, 12

APHIS should regulate only those organisms that 13

pose such a risk. Based upon experience gained to 14

date APHIS should exclude or exempt from regulation 15

under 340 all organisms for which there is no 16

scientifically plausible reason to believe that 17

they are likely to present plant health risk. 18

Regarding question 2, APHIS already has 19

existing regulations by which it regulates noxious 20

weeds. More than 100 risk assessments of ag 21


33

biotech crops included consideration of weed risk 1

and APHIS has never affirmatively identified the 2

GE organism with increased weediness, much less 3

identified one to be a noxious weed. However, if 4

APHIS believes a product of ag biotech may be a 5

noxious weed, it has existing mechanisms in the PPA 6

and 7 CFR 360 to evaluate that risk and to impose 7

appropriate regulatory oversight. In fact, APHIS 8

has already used this mechanism to assess the 9

noxious weed risk of certain GE organisms. 10

Importantly, APHIS should refrain from 11

creating a contradictory level of standards with 12

regard to what it considers to be a noxious weed. 13

As APHIS stated in the preamble to its 2008 proposed 14

rule, noxious weeds are plants that are likely to 15

be aggressively invasive, have significant 16

negative impacts and are extremely difficult to 17

manage or control once established. Should APHIS 18

identify such a plant, GE or not, it has the 19

authority to regulate it. However, APHIS would 20

risk contorting the statutory authority beyond 21


34

logic and common sense if it were to use one 1

standard for identifying non-GE weeds and plants 2

as noxious weeds while using a different standard 3

for GE plants. A noxious weed is a noxious weed 4

regardless of its origin. 5

Regarding question 3, APHIS has 6

sufficient authority in the PPA to protect U.S. 7

agriculture from a list of plant pests and noxious 8

weeds. When writing and enacting the PPA in 2000, 9

many years after APHIS began regulating GE crops, 10

Congress had the opportunity but did not see a need 11

or value to provide USDA additional oversight of 12

GE crops, nor have they identified a specific need 13

to seek additional legal authority. In the 14

absence of an unidentified need APHIS' would run 15

the risk of appearing to seek to regulate products 16

derived from bio technology for the sake of 17

regulation per se rather than addressing a specific 18

protection goal. 19

Regarding question 4, BIO encourages 20

APHIS to use this opportunity to explore policy 21


35

actions that make implementation of its existing 1

regulations more consistent with the risk posed by 2

the activities it oversees. A few examples 3

include: First, APHIS should continue to strive 4

to meet its 2011 regulatory timeline for making 5

final determinations on petitions in order to 6

improve the time limits and predictability of its 7

reviews. 8

Second, APHIS should continue to expand 9

the use of the extension process to more quickly 10

remove from regulation organisms similar to those 11

already evaluated by APHIS and found not to pose 12

plant pest risk. 13

Third, APHIS should identify 14

categories of organisms that can be excluded or 15

exempted from regulation because there is no 16

scientifically plausible reason to believe they 17

might present a plant pest risk. 18

Fourth, APHIS should ensure that 19

oversight of field trials is proportionate to the 20

actual risk posed by the activity. APHIS should 21


36

reverse this trend towards greater regulatory 1

burden imposed upon notification. Notifications 2

were originally intended to be a streamlined 3

version of the permit process for those organisms 4

familiar to APHIS. Oversight and notification has 5

grown so much over time, however, that the 6

regulatory burden is barely distinguishable from 7

that imposed on permits, if not greater. Further, 8

APHIS should refrain from changing which organisms 9

are eligible for notification, eroding the use of 10

the process by gradually pushing more organisms 11

into the permit process. 12

MR. GEORGE: Clint, I just want -- 13

MR. NESBITT: Finally -- 14

MR. GEORGE: You got two minutes. 15

MR. NESBITT: I'm wrapping up here. 16

Perfect. 17

MR. GEORGE: Okay. Great. Thank 18

you. 19

MR. NESBITT: And so finally, BIO 20

strongly urges APHIS to refrain from using 21


37

non-regulatory approaches when they become merely 1

a means to circumvent public comment and 2

rulemaking. APHIS should ensure that any 3

qualities it considers are fully consistent with 4

the statutory and regulatory authority, include 5

stakeholder input and are implemented only after 6

following the appropriate administered 7

procedures. 8

BIO welcomes the opportunity to provide 9

APHIS feedback on the functioning on the regulatory 10

system and how it may be improved in the future. 11

We strongly encourage APHIS to utilize its nearly 12

30 years of experience to ensure that oversight 13

remains consistent with APHIS' mission of 14

protecting U.S. agriculture from the impact of 15

plant pests and noxious weeds and that APHIS' level 16

of oversight is proportionate to the degree to 17

which the product of biotechnology may pose such 18

risks. 19

Thank you for your time and 20

consideration. 21


38

MR. GEORGE: Thank you, Clint. 1

So, we shall go to the next 2

pre-registered commenter, who is Adam Costanza. 3

Adam Costanza, if you're on the line, would you 4

please press one, then zero on your telephone 5

keypad? We'll open your mic and be glad to take 6

your comments. 7



MR. GEORGE: Adam, are you there? 10

MR. COSTANZA: Can you hear me now? 11

MR. GEORGE: Yes, we can. There we go. 12

Please go ahead. 13

MR. COSTANZA: Thank you for hosting 14

this forum, and I will comments online for the 15

Institute of Forest Biosciences. Thank you. 16

MR. GEORGE: Adam, could I ask you to 17

please just say your name and spell your name for 18

us, please? 19

MR. COSTANZA: Adam Costanza, A-D-A-M, 20

C-O-S-T-A-N-Z-A. 21


39

MR. GEORGE: Thank you. Please go 1

ahead. 2

MR. COSTANZA: So I wanted to thank you 3

for hosting this forum and I will provide comments 4

online for the Institute of Forest Biosciences -- 5

MR. GEORGE: Adam, I can't hear you. 6

Even when we could, it was breaking up a little bit. 7

Are you still there? 8

MR. COSTANZA: Yes, I'm still here. 9

MR. GEORGE: Okay. Please go ahead. 10

MR. COSTANZA: And, I'm sorry for the 11

poor connection. I just wanted to thank you for 12

hosting this forum, and I will provide my comments 13

another way, due the poor connection. 14

MR. GEORGE: Okay. So, you're going 15

to pass because of the connection. If you'd like 16

to perhaps call us back? That would be fine. We 17

might get a better connection if you were to call 18

back. 19

And in the meantime, we'll go to another 20

commenter. And we'll go back to ones who have 21


40

signed up to comment but have not yet commented. 1

We asked their names once before. That would be 2

Alejandra BedollaDiaz. If you're on the call, 3

please press one, then zero on your telephone 4

keypad. 5


MR. GEORGE: And not hearing that you 7

are, then we shall ask Randy Gordon, if you're on 8

the call, to please press one, then zero so that 9

we can take your comment. 10


MR. GEORGE: So we'll give Randy a 12

moment. Perhaps it's on mute? No. 13


MR. GEORGE: Okay. And that's 15

everybody that has signed up that we have on the 16

list. If there are others on the call who would 17

care to make a comment, anyone who would like to 18

comment can do so by simply pressing one, then zero 19

on your telephone keypad and letting us know that 20

you would like to comment. 21


41


MR. GEORGE: I see that Adam has let us 2

know that he will provide his comments online. 3

Is there anyone else on the phone who's 4

perhaps listening in who was not pre-registered to 5

comment who would like to comment? Now is the time 6

to do it. All you need to do is press one, then 7

zero on your touch-tone phone. We'll be glad to 8

take your comment. 9


MR. GEORGE: Okay. I will repeat one 11

last time that if you'd like to make a comment, just 12

press one, then zero. Hearing, however, that no 13

one has indicated their desire to make a comment, 14

we shall take a break. And what we'll do, there 15

will be a slide that will come up that indicates 16

that we are in a break. You will hear music. If 17

you're on the call and would like to make a comment, 18

just press one, then zero at any time. We will see 19

that and we will invite you to make a comment and 20

open your mic. 21


42

So we're going to take a little break. 1

We'll come back every 5 or 10 minutes or so just 2

to remind anyone who may still be on the call that 3

we're here to take your comments and we welcome 4

those comments. 5

Meanwhile, if any of you who have 6

already commented would care to say more or to 7

elaborate on your comments, you can do so by 8

pressing one, then zero on your touch-tone phone. 9

So are there any commenters in the 10

queue? 11


MR. GEORGE: Seeing that there are 13

none, we're going to take a little break and we'll 14

be checking back in in the next five minutes or so. 15

Thanks very much. 16

(Whereupon, the above-entitled matter 17

went off the record at 6:42 p.m. and resumed at 6:51 18

p.m.) 19

MR. GEORGE: Okay. So we're back. 20

This is the engagement webinar on APHIS 21


43

Biotechnology Regulations. My name is Dick 1

George. I'm here with Neil Hoffman. We're here 2

to receive your comments. If you would care to 3

comment, all you need to do is press one, then zero 4

on your telephone keypad and we'll see that and 5

we'll be happy to take your comment. 6

Also, if anyone who has already 7

commented would care to add to their comments, 8

please feel free to do so. Just hit one, then zero 9

on your telephone keypad, please. 10

So is there any -- we have no commenters 11

in the queue. We'll give it a few more seconds. 12


MR. GEORGE: So in that case, we shall 14

take another break for a few minutes. We'll be 15

checking back in every five or six minutes or so. 16

And again, you can hit one and zero at any time and 17

we'll open up the line to take your comments. 18

Thank you. We'll take another break. 19




44

p.m.) 1

DR. HOFFMAN: Okay. We're back to see 2

if anyone else is there to make a comment. If 3

you're interested in making a comment, you can 4

please do so now by pressing your telephone keypad 5

and pressing one and then zero. Again, if you'd 6

like to make a comment, please press one and zero. 7

We're at the public meeting for 340. 8

We have a comment. 9

MR. GEORGE: Terrific. 10

DR. HOFFMAN: Terrific. 11



DR. HOFFMAN: Please state your name 14

and spell it for us first. 15

MS. LIPSTREU: Good evening. My name 16

is Amalie Lipstreu. Can you hear me okay? 17

DR. HOFFMAN: Yes. Yes, we can. 18

Spell your name, Amalie. 19

MS. LIPSTREU: My name is spelled 20

A-M-A-L-I-E. And the last name is 21


45

L-I-P-S-T-R-E-U. 1

DR. HOFFMAN: Thank you. 2

MS. LIPSTREU: And I am with the Ohio 3

Ecological Food and Farm Association, otherwise 4

known as OFA for short. OFA is a grassroots 5

organization representing farmers, researchers 6

and interested consumers. OFA also operates one 7

of the country's oldest USDA-accredited organic 8

certification agencies. 9

Thank you for the opportunity to 10

provide verbal comments on how biotechnology 11

should be regulated. I just have a few comments 12

to share and will be following up these verbal 13

comment with more detailed written comments in the 14

future. 15

We believe that stronger regulations 16

can and should be implemented under the current 17

authority within the Plant Protection Act. 18

Specifically, mandatory contamination prevention 19

practices are needed for users of GE crops, as well 20

as fair compensation mechanisms when contamination 21


46

occurs. 1

Predictability and uncertainty were 2

brought up earlier this evening. Those are very 3

important goals for all businesses. 4

Unfortunately, for organic and non-GE producers 5

the level of business certainty is significantly 6

reduced as a result of the contamination by 7

genetically engineered crops. 8

In response to the first question, we 9

believe that new regulations should be 10

process-based and that no GE products should be 11

unregulated, as again their impact to organic and 12

non-GE producers is very real and affects the 13

viability of both the organic and the conventional 14

non-GE farming industry. 15

Contrary to being anti-science, we 16

believe in sound science on GE technology. And we 17

also ask that in determining what is regulated 18

APHIS should ask whether there have been 19

independent longitudinal and peer-reviewed 20

studies on the proposed biotechnology. 21


47

APHIS should implement its Noxious Weed 1

Authority to regulate GE crops and other plants and 2

this goal of needing to protect against increased 3

herbicide and pesticide use and the damages 4

associated with that use, as well as their impacts 5

to beneficial organisms, including pollinators. 6

Finally, non-regulatory solutions are 7

not effective when stopping the spread of GE 8

contamination. It's very important that there is 9

regulatory oversight and mandatory prevention 10

measures in place to protect organic and non-GE 11

producers. 12

Again, I really appreciate the 13

opportunity to provide some comment. And thank 14

you for the time. 15

DR. HOFFMAN: Thank you. 16

MR. GEORGE: Thanks very much. 17

DR. HOFFMAN: Any other commenters who 18

would like to speak? If you wish to speak, please 19

press your telephone keypad one and then zero. 20



48

DR. HOFFMAN: Anyone else? 1


DR. HOFFMAN: Give it one more minute 3

or so and then we'll take another five-minute break 4

or so. 5


DR. HOFFMAN: Okay. Doesn't sound 7

like there are any takers. So we're going to sign 8

off very briefly again for about five minutes or 9

so. 10

MR. GEORGE: Thank you. Yes, if you 11

want to press one and then zero any time even during 12

this break, we shall see that and we'll come back 13

on to receive your comment. 14

Now having said that, we'll take a short 15

break and be back shortly. Thanks. 16



p.m.) 19

MR. GEORGE: Okay. We're back. This 20

Dick George. I'm with Neil Hoffman. We're here 21


49

to take your comments on APHIS biotechnology 1

regulations. If anyone would care to make a 2

comment, please press one, then zero on your 3

telephone keypad. And we'll see that and we'll be 4

happy to take your comment. 5

And while we hope someone is in the 6

process of doing that, I will explain because we 7

had a question, the comments that are being made 8

in this meeting and the other two meetings which 9

will follow in the next two weeks will be 10

transcribed, and they will be available on our 11

website within the next two, three weeks or so. So 12

that website is 13

www.aphis.usda.gov/APHISVirtualMeetings, all one 14

word. That's 15

www.aphis.usda.gov/APHISVirtualMeetings. 16

Transcriptions will be there within the next two 17

or three weeks. 18

So seeing that there's no one in our 19

queue, we shall repeat that if you would like to 20

make a comment, just press one, then zero on your 21


50

telephone keypad. We'll see that and we will open 1

your mic and be glad to take your comment. 2

So seeing that there is no one in the 3

queue, we'll take another break and come back in 4

another six, seven minutes or so. Thanks so much. 5



p.m.) 8

DR. HOFFMAN: Hello, I'm Neil Hoffman. 9

I'm here with Dick George and we're taking your 10

comments on revisions to 340. If you would like 11

to make a public comment today, please press your 12

one and zero on your telephone keypad. Is there 13

anyone out there who would like to make a comment? 14


DR. HOFFMAN: We don't have anyone in 16

the queue now. We'll stay on here for another 17

minute or so. If you'd like to make a comment, 18

please one and then zero. 19


DR. HOFFMAN: There seemed to have been 21


51

someone who had pressed their keypad while we were 1

on mute. Was that by accident or do you want to 2

speak? 3


DR. HOFFMAN: Please press one and then 5

zero. 6


DR. HOFFMAN: Okay. No one's in our 8

queue still, so I think we're going to go back on 9

break. While we're on break if you want to hit one 10

and then zero, we will know that you want to speak 11

and we'll come right back on the air. We promise 12

you. 13



p.m.) 16

MR. GEORGE: Hi. Welcome back. I'm 17

Dick George. I'm here to take comments on APHIS 18

regulation of biotechnology. We invite you to 19

make a comment if you care to. If you're on the 20

phone, please press one, then zero on your 21


52

telephone keypad. We will see that on our screen 1

and we'll be glad to open your mic and take your 2

comment. 3

So is there anyone who would like to 4

make a comment at this time? We'll be here until 5

9:00 p.m. Eastern Time tonight to take comments. 6

And I see that there's no one in the 7

queue. And seeing that, we shall take another 8

break for about eight minutes or so, eight or 10 9

minutes, I think. However, if during that time 10

you'd like to make a comment, press one, then zero. 11

We'll see that and we'll come right back on. So, 12

we'll see you after the break, if not sooner. 13

Thanks so much. 14



p.m.) 17

MR. GEORGE: Hi. I'm Dick George back 18

at our meeting to take public comment on the subject 19

of APHIS biotechnology regulations. We'd invite 20

anyone who's on the call who would care to make a 21


53

comment press one, then zero on your telephone 1

keypad. We'll see that and we will be more than 2

happy to open your mic to take your comment. 3

And while we're waiting to see if anyone 4

takes me up on that, I will mention that there be 5

two more public comment meetings. One will be next 6

week, the 12th. And another on the 20th. And so, 7

those meetings will be just like this one, the same 8

format. 9

So we welcome your comments. Also, 10

I'll mention that all of the comments made here 11

tonight will be transcribed and available on our 12

website, which is 13


So seeing that we still no one in the 15

queue, we shall take another break. And I invite 16

you to press one and then zero at any time during 17

the break. We'll see that and immediately come 18

back on to receive your comment. 19

So thanks for being with us and we'll 20

be checking back here in another 5 or 10 minutes 21


54

or so. Thanks so much. 1



p.m.) 4

MR. GEORGE: Hi, and welcome back. 5

This is our meeting to take public comments on the 6

subject of APHIS biotechnology regulations. If 7

you'd like to make a comment, please press one and 8

then zero on your telephone keypad and we will see 9

that and welcome to make a comment. 10

So at this time would anyone like to 11

make a comment, please? One, then zero. 12



MR. GEORGE: Beautiful. 15

MR. LEHMANN: Yes, hi. Can you hear 16

me? 17

MR. GEORGE: We sure can. If you would 18

please start by saying your name and spelling your 19

name for us so we get the spelling right, and then 20

go ahead. 21


55

MR. LEHMANN: Okay. Of course. I'm 1

Brian Lehmann, B-R-I-A-N, L-E-H-M-A-N-N. 2

MR. GEORGE: Thank you, Brian. Go 3

ahead. 4

MR. LEHMANN: All right. USDA Organic 5

is probably the largest consumer market-driven 6

growth sector in American agriculture, yet only 7

organic farmers are responsible for creating 8

buffer zones, testing at-risk seed, delaying 9

plantings, selecting pollinators and more all to 10

avoid unwanted GMO cross-contamination. 11

The biotech side has argued that since 12

organic commands a premium price at market, those 13

conditions are somehow justified. How is that? 14

Isn't the premium a result of market demand and hard 15

work? Yet under current circumstances the U.S. 16

organic cannot even meet its own demand. This 17

would seem a perverse fulfillment of the biotech 18

mantra that organic cannot feed the world. But the 19

absence of containment of unwanted gene flow, 20

organic can have a very hard time indeed. So why 21


56

should biotechnology get carte blanche for 1

operations? 2

Take question No. 1: Should APHIS 3

regulate based on characteristics or process? One 4

might wonder why it's either/or, but all crops, 5

including new generations that are products of 6

biotechnology should be regulated. Biotech is a 7

radical departure from natural hybridization. 8

You might say that amounts to some philosophical 9

exception, but statutory language clearly supports 10

the concept qualifying unwanted GMO 11

cross-contamination as damaging or injurious. 12

The Department might not want to admit 13

it. It doesn't assert it when its position is 14

given great deference by the courts, but what was 15

the proposed partial deregulation of GMO alfalfa 16

if not isolation distances based on statutory 17

authority? So the authority is there, even under 18

current language. 19

On to question 2: Should APHIS add 20

noxious weed provisions to biotechnology 21


57

regulation? Absolutely. Because APHIS cannot 1

overlook risk assessments including on newer GMO 2

generations perhaps not derived from or allied with 3

so-called plant pests. The statutory language for 4

noxious weeds includes public health and 5

environmental considerations. And by the way, the 6

definition of "weed" includes any undesirable or 7

troublesome plant. 8

But again, even under noxious weed 9

provisions, unwanted GMO cross-contamination can 10

be considered damaging or injurious. You know, 11

USDA's got to enforce the law. Patent holders must 12

be held accountable if prevented measures fail. 13

It doesn't make sense for organic to get no respect 14

in this regard. 15

I think USDA is conducting a survey to 16

see if there's a problem. Well, if an organic 17

grower has a load rejected and all parties have 18

taken appropriate precautions, the patent holder 19

of the offending trait or traits is responsible for 20

pecuniary damages. That's the type of protection 21


58

consumers and suppliers are entitled to under the 1

PPA. And by the way, there's already enough 2

concern to warrant that all organic corn get tested 3

for cause so that consumers without contracts are 4

equally protected, but that's an argument for the 5

National Organic Program. But if we in the organic 6

community are entitled to protections under PPA and 7

regulators aren't providing it, then that's 8

objectionable. 9

And I would just close by saying UN 10

level studies have recently identified 11

agroecological reforms as needed to feed the world, 12

so we don't really need to pretend that 13

biotechnology is helping. Thanks for your 14

consideration of these remarks. 15

MR. GEORGE: Thank you for your 16

comments. 17

If there's anyone else on the phone who 18

would like to make a comment, please let us know 19

by pressing one and then zero on your telephone 20

keypad. 21


59


MR. GEORGE: One and then zero on your 2

telephone keypad. 3


MR. GEORGE: If not, we shall take a 5

break. We'll be checking back every six or eight 6

minutes or so. And even during the break if you'd 7

like to comment, just press one and then zero. 8

We'll see on our screens and we'll open your mic 9

and gladly take your comment. 10

So with that, we'll take another short 11

break. Thanks so much. 12



p.m.) 15

MR. GEORGE: Okay. We're back. I'm 16

Dick George. We're here to take your comments on 17

APHIS biotechnology regulations. We welcome your 18

comments. If you'd like to join us and to make a 19

comment, please press one and then zero on your 20

telephone keypad. 21


60

I will mention while we have the chance 1

that if you'd like to make a written comment instead 2

of a spoken one, you can go to regulations.gov, 3

www.regulations.gov, and you can leave a written 4

comment there. What you could do is enter the 5

search box -- at regulations.gov you would enter 6

APHIS-2015-0036 in the search box. That will take 7

you to this docket where you can make your comments. 8

APHIS-2015-0036 at regulations.gov. 9

Seeing that we have no one in the queue, 10

we'll take another break and be back in say 10 11

minutes or so. In the meantime, even during the 12

break, if you'd like to make a comment, press one 13

then zero. We'll see it and we'll come back on to 14

receive your comment. Thanks so much. 15



p.m.) 18

MR. GEORGE: Okay. I am Dick George. 19

We're taking comments on APHIS biotechnology 20

regulations. We welcome a comment from you. And 21


61

if you would care to make one, please press one and 1

then zero on your telephone keypad and we'll be glad 2

to take your comment. 3

I will mention while we have the chance 4

that the transcripts from the comments tonight will 5

be placed on our website within the next couple of 6

weeks. And our website is www.aphis, A-P-H-I-S, 7

.usda.gov, G-O-V/APHISVirtualMeetings. The 8

transcripts will be posted there within the next 9

couple of weeks. And also you will find there a 10

lot of background information about our 11

regulations and some history of attempts to adjust 12

our regulations over the years. 13

So if you'd like to make a written 14

comment, that's also possible. You can make that 15

comment any time through June 22nd at 16

regulations.gov is the website. And you would 17

simply enter the docket number, which is APHIS, 18

A-P-H-I-S, -2015-0036. Put that into the search 19

box at regulations.gov. It will take you to a 20

place where you can make your written comment, if 21


62

you care to. 1

Having said that, I will invite once 2

again anyone on the phone to make a comment by 3

pressing one and then zero. 4


MR. GEORGE: And seeing that we have 6

none, we will take another break and we'll be back 7

in I'm going to say 10 minutes or so. So we'll see 8

you then. Press one and then zero in the 9

intervening time if you care to and we'll come back 10

on immediately and take the call. Thanks so much. 11



p.m.) 14

MR. GEORGE: Hi, I'm Dick George and 15

we're back. We're here to take your comments on 16

APHIS regulation of biotechnology, and we welcome 17

comments you have. We'd invite you to do so by 18

pressing one and then zero on your telephone 19

keypad, and then we will welcome you on to the call 20

and take your comment. 21


63

MR. GEORGE: We will be stopping 1

tonight at 9:00, in about 01 10 minutes Eastern 2

Time. And so, we welcome you to make a comment now. 3

And looking at our board, I see that there is no 4

one in the queue at the moment. If you'd like to 5

make a comment, we have 10 more minutes to take 6

comments. If you've already made a comment and 7

you'd like to elaborate on it, we welcome that as 8

well. 9

So, I see that there is no one in our 10

list at the moment, and so we'll take another break 11

and we'll come back in just a minute or so before 12

9:00 to take any final comment that anyone may have 13

and then we'll close the meeting from there. 14

So press one, then zero, please to make 15

a comment. 16


MR. GEORGE: And seeing that there are 18

none, we'll break until just a couple minutes 19

before 9:00. Thanks so much. 20



64


p.m.) 2

MR. GEORGE: Okay. We're back. And 3

we'll ask for the last time that if anyone would 4

like to make a comment on APHIS regulation of 5

biotechnology, please do so at this time by 6

pressing one and then zero on your telephone 7

keypad, and we'll be happy to take your comment. 8

So we'll take a second or two to see if 9

anyone takes us up on this offer. 10


MR. GEORGE: And it appears that no one 12

is. And so, we shall bring the meeting to a close. 13

So we'd like to thank everyone for participating 14

today in our public engagement webinar. The 15

transcription of this virtual meeting will be 16

available at our website, 17

www.aphis.usda.gov/APHISVirtualMeetings within 18

three weeks. 19

We will also post a link to a survey 20

there. Please click on it and complete the survey. 21


65

That will help us make these meetings better in the 1

future. 2

Keep in mind that you can leave written 3

comments through June 22nd at regulations.gov. 4

Enter APHIS-2015-0036 in the search box. 5

We have two more of these webinars 6

scheduled: May 12th from 5:00 to 8:00 p.m. and May 7

20th from 4:00 to 7:00. Both times are Eastern 8

Daylight Time. The webinars will be the same as 9

the one tonight. They vary only by date and time. 10

Those wishing to attend and/or comment at those 11

webinars are encouraged to register, please, at the 12

website I gave you a moment ago, 13


Thanks again for joining us. This 15

concludes tonight's webinar. 16


went off the record at 9:01 p.m.) 18

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Documents

NEAL R. GROSS - USDA-APHIS · In addition to tonight's webinar two . 21. more have been scheduled for May 12th and May 20th. NEAL R. GROSS. COURT REPORTERS AND TRANSCRIBERS 1323 RHODE